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基于虚拟现实的辅助软件用于胸腔镜手术后疼痛的有效性和安全性:一项随机对照试验的研究方案

Effectiveness and safety of adjuvant software based on virtual reality for post-thoracoscopic surgery pain: study protocol for a randomized controlled trial.

作者信息

Feng Xijia, Guo Wei, Jiang Benyuan, Li Tong, Lu Yi, Xu Song, Zhong Wenzhao, Li Hecheng

机构信息

Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.

出版信息

Trials. 2025 Aug 13;26(1):290. doi: 10.1186/s13063-025-08975-8.

Abstract

BACKGROUND

Postoperative pain can significantly impair functional recovery and diminish the quality of life in patients who have undergone thoracoscopic surgery. Virtual reality (VR), by leveraging cognitive-behavioral intervention techniques and redirecting attention from noxious stimuli, holds promise as a modality to alleviate postoperative pain. Despite this potential, current VR software for postoperative care predominantly emphasizes physical therapy and rehabilitation, often overlooking the integration of pain management strategies. The primary objective of our study is to evaluate the effectiveness and safety of an adjunctive VR-based software for pain control following thoracoscopic surgery.

METHODS

This is a prospective, multicenter, open-label, randomized controlled trial involving 215 patients who have undergone thoracoscopic surgery. Participants will be randomly allocated to one of two parallel groups. The experimental group will receive postoperative adjuvant analgesic software in addition to standard postoperative pharmacological analgesia, while the control group will receive only standard postoperative pharmacological analgesia. Pain intensity will be assessed using the numerical rating scale (NRS) at pre-intervention and at 24 and 48 h post-surgery. The primary outcome measure will be the effectiveness of the VR-based adjuvant analgesic software, as assessed by the reduction in NRS scores after the second intervention at 48 h postoperatively compared to pre-intervention baseline at 24 h postoperatively, and the secondary outcome measure will assess its safety profile.

DISCUSSION

Our study marks a pioneering effort to incorporate VR-based adjuvant software into the postoperative pain management regimen. We endeavor to explore an innovative approach to deliver evidence-based pain treatments. The findings of this trial aim to shed light on the potential benefits of VR as a complementary tool to traditional analgesic therapies in the context of postoperative pain management following thoracoscopic procedures.

TRIAL REGISTRATION

Our protocol was retrospectively registered in the Chinese Clinical Trial Registry on August 2, 2024. The registration number was ChiCTR2400087741.

摘要

背景

术后疼痛会严重妨碍接受胸腔镜手术患者的功能恢复并降低其生活质量。虚拟现实(VR)通过运用认知行为干预技术并将注意力从有害刺激上转移,有望成为缓解术后疼痛的一种方式。尽管有这种潜力,但目前用于术后护理的VR软件主要强调物理治疗和康复,常常忽视疼痛管理策略的整合。我们研究的主要目的是评估一种基于VR的辅助软件用于胸腔镜手术后疼痛控制的有效性和安全性。

方法

这是一项前瞻性、多中心、开放标签、随机对照试验,涉及215例接受胸腔镜手术的患者。参与者将被随机分配到两个平行组之一。实验组除接受标准的术后药物镇痛外,还将接受术后辅助镇痛软件治疗,而对照组仅接受标准的术后药物镇痛。在干预前以及术后24小时和48小时使用数字评分量表(NRS)评估疼痛强度。主要结局指标将是基于VR的辅助镇痛软件的有效性,通过术后48小时第二次干预后NRS评分相对于术后24小时干预前基线的降低来评估,次要结局指标将评估其安全性。

讨论

我们的研究标志着将基于VR的辅助软件纳入术后疼痛管理方案的开创性努力。我们致力于探索一种创新方法来提供循证疼痛治疗。该试验的结果旨在阐明在胸腔镜手术后疼痛管理背景下,VR作为传统镇痛疗法的补充工具的潜在益处。

试验注册

我们的方案于2024年8月2日在中国临床试验注册中心进行了回顾性注册。注册号为ChiCTR2400087741。

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